There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a
good benefit/risk profile. Based on the recent findings of encouraging results obtained with
propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is
expected to be of significant benefit in the management of the condition. The present study
has been designed to confirm efficacy of propranolol in severe IH by demonstrating
superiority over placebo and to document the safety profile of propranolol in this
indication.

Primary outcome: Complete/nearly complete resolution of the target IH at W24 compared to baseline based on the intra-patient blinded centralised independent qualitative assessments of W24 photographs.

Secondary outcome: -Success/failure based on the investigator qualitative assessment of complete resolution at W48. -Time to first sustained improvement based on centralised qualitative assessments of paired patient-visits

Detailed description:
Primary objective The primary objective of this study is to identify the appropriate dose
and duration of propranolol treatment and demonstrate its superiority over placebo based on
the complete/nearly complete resolution of target IH at W24.